Stryker Faces First Lawsuit for Recalled Hip Implants
8/9/12 from Medical Design Technology
South Florida law firm Searcy Denney Scarola Barnhart & Shipley PA (Searcy Denney) announced today that it has filed the first lawsuit against Howmedica Osteonics Corporation, dba Stryker Orthopaedics, claiming damages caused by the company’s defective and recalled Rejuvenate and ABG II hip implant systems.
The suit was filed in Bergen County, New Jersey Superior Court, by Searcy Denney and Weitz & Luxenberg on behalf of plaintiffs Dianne and Phillip Pingel. The plaintiffs allege that the defendant was negligent and failed to use reasonable care for the safety and well-being of patients in the development, testing, marketing, packaging, and selling of the defective product.
On July 4, 2012, Stryker posted a national recall of the Rejuvenate and ABG II hip implant systems apparently after receiving multiple reports of the premature failure of those implants.
“That recall is tantamount to an unequivocal admission by the defendant as to the dangers and defects of their product,” said Cal Warriner, a shareholder at Searcy Denney, who represents Mr. and Mrs. Pingel. “Stryker must now redress the damages that these defective systems have caused.”
The lawsuit seeks compensatory and punitive damages to cover the medical, hospital, rehabilitation, and pharmaceutical costs incurred by the plaintiffs as a direct result of the implant failures.
“Currently there are more than 60 adverse event reports filed with the FDA’s MAUDE incident reporting system,” Warriner added. “The Rejuvenate device has been on the market since 2009 and the number of incidents has been climbing exponentially since the beginning of 2012.
“These devices are supposed to last 15 to 20 years. When they fail in huge numbers in less than two years post-implant, there is a serious problem.”
Dianne Pingel had the misfortune of being implanted with two defective Stryker Rejuvenate hip implants. One of the implants failed, due to heavy metal ion contamination and poisoning caused by fretting and corrosion. During her revision surgery, her femur fractured. Four weeks later, her hip dislocated and her femur fractured again. She has undergone a third surgery recently and is currently confined to a nursing home. In the future, she will need to undergo additional surgery to remove the defective Rejuvenate implant from her other hip. Her recovery has been complicated by pseudotumor formation, bone necrosis, and adverse soft tissue reactions relating to the implant corrosion.
Stryker hip implants have been a particular source of controversy since April 2012, when Howmedica Osteonics issued an Urgent Field Safety Notice to surgeons and hospitals that cited failures at the taper neck junction causing corrosion and fretting. The defendant had previously claimed that these problems would not occur due to the new design of the system.
The plaintiffs have requested a jury trial.